注册号: Registration number: |
ChiCTR-DOC-16008645 |
最近更新日期: Date of Last Refreshed on: |
2016-06-15 |
注册时间: Date of Registration: |
2016-06-15 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
帕金森病核素显像及其他生物学标志物在临床诊断和治疗的研究 |
Public title: |
The study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's disease |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
帕金森病核素显像及其他生物学标志物在临床诊断和治疗的研究 |
Scientific title: |
The study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's disease |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
林伟 |
研究负责人: |
林伟 |
Applicant: |
Lin Wei |
Study leader: |
Lin Wei |
申请注册联系人电话: Applicant telephone: |
+86 13812512187 |
研究负责人电话: Study leader's telephone: |
+86 13812512187 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
smithlinwx@aliyun.com |
研究负责人电子邮件: Study leader's E-mail: |
smithlinwx@aliyun.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
江苏省无锡市兴源北路101号 |
研究负责人通讯地址: |
江苏省无锡市兴源北路101号 |
Applicant address: |
101 North Xingyuan Road, Wuxi, Jiangsu, China |
Study leader's address: |
101 North Xingyuan Road, Wuxi, Jiangsu, China |
申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
江苏省无锡市解放军101医院 |
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Applicant's institution: |
101th Hospital of PLA |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
L2016005 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
解放军101医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of 101th Hospital of PLA |
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伦理委员会批准日期: Date of approved by ethic committee: |
2016-01-02 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
解放军101医院 |
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Primary sponsor: |
101th Hospital of PLA |
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研究实施负责(组长)单位地址: |
江苏省无锡市兴源北路101号 |
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Primary sponsor's address: |
101 North Xinyuan Road, Wuxi, Jiangsu, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
self-financing |
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研究疾病: |
帕金森病 |
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Target disease: |
Parkinson Disease |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
诊断试验 |
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Study type: |
Diagnostic test |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
研究目标:1 通过核素显像准确的对于帕金森病患者进行诊断,并尽可能成为早期诊断的有力工具,提早并确立早期PD疾病干预时间窗;2 探索出现运动并发症患者的显像特征,并对可能出现运动并发症的PD患者进行早期预判断,为早期选择合适治疗方案避免或延缓出现运动并发症打下基础。 |
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Objectives of Study: |
1. to dignosis the potential PD patients by radionuclide imaging as early as possible; 2. to explore the imaging characteristics of motor complications of patients and motor complications in PD patients. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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纳入标准: |
帕金森病早起患者,帕金森病运动并发症患者; |
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Inclusion criteria |
early stage PD, motor-complictions PD |
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排除标准: |
继发性帕金森病患者 |
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Exclusion criteria: |
secondery PD |
研究实施时间: Study execute time: |
从From2016-07-01至To 2018-06-30 |
征募观察对象时间: Recruiting time: |
从From2016-07-01至To 2017-06-30 |
诊断试验: Diagnostic Tests: |
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研究实施地点: Countries of recruitment and research settings: |
测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
非随机研究 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
non-randomized studies |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
2020-01-01,在线 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
2020-01-01,online |
数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
用本院开发帕金森数据库 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Using databas developed by out institute |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |